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Memory Preservation of Hippocampal Avoidance Whole Brain Radiotherapy

The Memory Preservation Study of Whole Brain Radiotherapy With Hippocampal Avoidance for Patients With Brain Metastases

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03247127
Enrollment
30
Registered
2017-08-11
Start date
2017-03-27
Completion date
2020-12-31
Last updated
2018-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases, Neurocognitive Function

Keywords

hippocampal avoidance whole brain radiotherapy (HA-WBRT), brain metastases, memory preservation, neurocognitive function

Brief summary

The study aimed to investigate the memory preservation and neurocognitive function protection of hippocampal avoidance whole brain radiotherapy (HA-WBRT) among people who speak Mandarin Chinese or Taiwanese.

Detailed description

Brain metastasis is very common, about 30% incidence rate for all patients with a diagnosis of cancer. The rising incidence of brain metastasis is most likely due to recent advances in systemic therapy, and use of magnetic resonance imaging (MRI). The most common primary site is the lung followed by breast. One of the standard treatments is whole brain radiotherapy; it can prolong the decline of neurocognitive function and improve quality of life. However, it can also cause decline in neurocognitive function as a late sequela. Memory impairment is the main cognitive function that affected by radiotherapy, and the neuronal stem cells located at hippocampal subgranular zone are highly sensitive to radiotherapy. There have been large randomized trials confirming that by HA-WBRT, the neurocognitive function decline can be reclaimed. In Taiwan, HA-WBRT is a popular and emerging treatment. However, not much study focused on its effects on neurocognitive function. The study is aimed to objectively investigate the memory preservation and neurocognitive function protection of HA-WBRT in people speaking Mandarin Chinese or Taiwanese by utilizing neurocognitive function test and QoL questionnaire.

Interventions

RADIATIONHippocampal avoidance whole brain radiotherapy

Planning target volume(PTV) for whole brain is Whole brain parenchyma plus2mm margin excluding metastases and HA region, 30Gy in 10 fractions will be delivered to PTVwhole brain. Bilateral Hippocampus will be contoured according to Radiation Therapy Oncology Group 0933 and hippocampal avoidance region is Hippocampi + 5mm margin. According to Radiation Therapy Oncology Group 0933 trial, dose to 100% of the hippocampus could not exceed 9 Gy, and maximal hippocampal dose could not exceed 16 Gy; dose to 100% of the hippocampus exceeding 10 Gy

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Hippocampal avoidance -whole brain radiotherapy(HA-WBRT), which delivers radiation to whole brain and moreover, to reduce mean dose to hippocampal neural stem-cell compartment to minimize the neurocognitive function impairment

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients with brain metastases, the brain metastases are located 5mm outside the hippocampus * Pathologically proven diagnosis of nonhematopoietic malignancy other than germ cell malignancy * No psychologic disorders * Radiation Therapy Oncology Group recursive partitioning analysis class I or II * First or second language: Mandarin Chinese or Taiwanese * Signed the inform consensus

Exclusion criteria

* Less than 20 years old * Leptomeningeal metastases or hydrocephalus * Previous radiotherapy to head and neck region * Creatinine \>1.5mg/dl * More than 2 extracranial metastases * Patients who cannot tolerate memory or neurocognitive function test or cannot complete QoL questionnaire

Design outcomes

Primary

MeasureTime frameDescription
Changes of Memory immediate recall and delayed recallFrom baseline to 4 months after RT complete, tests are performed at baseline before radiotherapy begins, 2 months after radiotherapy complete and 4 months after radiotherapy complete.The memory battery is using Wechsler Memory Scale (Chinese), including Logical Memory I & II, Word Lists Ⅰ & II, Faces Ⅰ and spatial span.
Changes of general cognitive functionFrom baseline to 4 months after RT complete, tests are performed at baseline before radiotherapy begins, 2 months after radiotherapy complete and 4 months after radiotherapy complete.General cognitive function are tested using cognitive abilities screening instrument, CASI for screening and to test cognitive function as a whole.

Secondary

MeasureTime frameDescription
Changes of Quality of lifeFrom baseline to 4 months after RT complete, the participants are requested to fill in the questionnaire of quality of life at baseline before radiotherapy begins, and 2 months after radiotherapy complete and 4 months after radiotherapy complete.Quality of life are assessed using The Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire

Countries

Taiwan

Contacts

Primary ContactPen-Tzu Fang, MD
ptmonicafang@gmail.com886-7-3121101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026